Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL

NCT04386577 | Unknown Phase 3 DMC

• 2 other identifiers: 2016p001917R01HL131674-01
• Study Type: interventional
• Target: 1,054
• Locations: 1 country
• Sites: 1

Brief Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) was a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL-CTSC cohort and will examine whether vitamin D or fish oil supplementation has beneficial effects on cellular aging.

Conditions

Aging

Keywords

vitamin D, omega-3 fatty acid, telomere length, inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in telomere length

  Leukocyte telomere length (LTL) will be measured using quantitative polymerase chain reaction method at the baseline, year 2 and year 4. we will examine the effect of randomization to vitamin D (primary Aim 1 and or fish oil (primary Aim 2) compared o placebo is different over time on changes in telomere length.

  4 years

Secondary Outcomes (1)

• Changes in Inflammation markers

  4 years

Study Arms (4)

Vitamin D + fish oil

ACTIVE COMPARATOR

Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Each capsule contains 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA).

Dietary Supplement: Vitamin D3 (cholecalciferol); Drug: fish oil

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Dietary supplement: Fish oil placebo

Dietary Supplement: Vitamin D3 (cholecalciferol)

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Dietary supplement: Vitamin D3 placebo

Drug: fish oil

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

Dietary supplement: Vitamin D3 placebo Dietary supplement: Fish oil placebo

Dietary Supplement: Vitamin D3 (cholecalciferol); Drug: fish oil

Interventions

Vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

Eligible participants were assigned by chance to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. At baseline, year 2 and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women's Hospital. During CTSC visits, participants have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.

Vitamin D + fish oil; Vitamin D + fish oil placebo; Vitamin D placebo + fish oil placebo

fish oil DRUG

Eligible participants were assigned by chance to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. At baseline, year 2 and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women's Hospital. During CTSC visits, participants have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.

Also known as: Omega-3 fatty acid

Vitamin D + fish oil; Vitamin D placebo + fish oil; Vitamin D placebo + fish oil placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subcohort of 1,054 participants in VITAL (NCT 01169259) who are receiving detailed health assessments at a Clinical and Translation Science Center at Boston are eligible to participate in this ancillary study:

Sponsors & Collaborators

• Augusta University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Cholecalciferol; Fish Oils; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Oils; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids

Study Officials

• Yanbin Dong, MD, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents Professor

Model Details: VITAL is a 2 x 2 factorial randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: May 13, 2020
• Study Start: August 19, 2016
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

US (1)